Pharmacy Prior Authorization Non-Formulary and Prior Authorization Guidelines

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1 Pharmacy Prir Authrizatin Nn-Frmulary and Prir Authrizatin Guidelines Scrll dwn t see PA Criteria by drug class, r Ctrl+F t search dcument by drug name Nn-preferred Medicatin Guideline Medicatins requiring Prir Authrizatin Fllwing criteria guidelines will be applied t all Nn-preferred drugs. In additin, sme drugs classes will have additinal criteria that will apply. Please see drug specific guidelines. Is there any reasn the patient cannt be changed t a preferred drug within the same class? Acceptable reasns include: Allergy t preferred drug. Cntraindicatin t r drug-t-drug interactin with preferred drug. Histry f unacceptable/txic side effects preferred drug. Patient s cnditin is clinically stable; changing t a preferred drug might cause deteriratin f the patient s cnditin. The requested drug may be apprved if bth f the fllwing are true: There has been a therapeutic failure f n less than a nemnth trial f at least ne preferred drug within the same class. The requested drug s crrespnding generic (if a generic is available and cvered by the State) has been attempted and failed r is cntraindicated. Requests fr Medicatins requiring Prir Authrizatin (PA) will be reviewed based n the PA Guidelines/Criteria fr that medicatin. Scrll dwn t view Minimum f 3 mnths, depending n the diagnsis, t determine adherence, efficacy and patient safety mnitring Minimum f 6 mnths Maintenance medicatins may be apprved Indefinite As dcumented in the individual guideline

2 Medicatins requiring Step Therapy the PA Guidelines fr specific medicatins. Medicatins that d nt have a specific PA guideline will fllw the Nn-Preferred Medicatin Guideline. Additinal infrmatin may be required n a case-by-case basis t allw fr adequate review. Medicatins that require Step Therapy (ST) require trial and failure f frmulary agents prir t their authrizatin. If the prerequisite medicatins have been filled within the specified time frame, the prescriptin will autmatically prcess at the pharmacy. Prir Authrizatin will be required fr prescriptins that d nt prcess autmatically at the pharmacy. Indefinite Quantity Level Limits Prescriptin requests that exceed established QLLs will require prir authrizatin. Drugs that are subject t additinal utilizatin management requirements (e.g., nn-frmulary, clinical prir authrizatin, step therapy) must meet the clinical criteria and medical necessity fr apprval in additin t any established QLLs. Apprval f QLL exceptins will be cnsidered after the medicatin specific prir authrizatin guidelines and medical necessity have been reviewed. Authrizatin Criteria Fr Quantity Limit Exceptins: Quantities that Exceed FDA Maximum Dse: Patient has had an inadequate respnse t the same medicatin at a lwer dsage and the inadequate respnse is nt due t medicatin nn-adherence Patient is tlerating the medicatin at a lwer dsage Requested dse is included in drug cmpendia r evidencebased clinical practice guidelines fr the same indicatin; OR A published, randmized, duble blind, cntrlled trial demnstrating the safety and efficacy f the requested dse fr the indicatin is submitted with the request Quantities that d nt Exceed FDA Maximum Dse (Dse Optimizatin): Patient had an inadequate respnse r intlerable side effects t 1 year 3 years Apprpriate Scenaris t Override Dse Optimizatin QLL: Manufacturer shrtage f higher strength Patient is unable t swallw tablet/capsule due t size: Cannt be crushed Lwer strength is smaller in size Effect f medicatin is wearing ff between dses Patient cannt tlerate entire dse in ne administratin

3 the ptimized dse; OR There is a manufacturer shrtage n higher strengths Quantities fr Medicatins that d nt have Established FDA Maximum Dse: Patient has had an inadequate respnse t the same medicatin at a lwer dsage Patient is tlerating the medicatin at a lwer dsage Requested dse is cnsidered medically necessary Onclgy - Antineplastic Agents Requests fr antineplastic agents will be reviewed based n the fllwing criteria: Member is under the care f an Onclgist Medicatin is prescribed fr an FDA-apprved indicatin OR fr a medically accepted indicatin as nted in the fllwing Cmpendia: NCCN Drugs and Bilgic Cmpendium r NCCN Clinical Practice Guidelines, categry 1, 2a, r 2b. Micrmedex DrugDex Clinical Pharmaclgy The dse prescribed is within the FDA-apprved range fr the indicatin and patient specific factrs (e.g., age, weight r BSA, renal functin, liver functin, drug interactins, etc) Requested medicatin is frmulary preferred. Requests fr nnpreferred r nn-frmulary antineplastics must meet ONE f the fllwing: Trials f frmulary preferred agents fr an adequate duratin were nt effective r were prly tlerated All ther frmulary preferred alternatives are cntraindicated based n the member s ther medical cnditins r drug interactins There are n frmulary preferred medicatins fr the patient s indicatin Member has a genetic mutatin that is resistant t the 3 mnths 1 year Clinically significant imprvement r stabilizatin f the disease state Adverse effect mnitring is cmpleted as recmmended in the FDA-apprved label Dse is adjusted as needed fr adverse effects based n the FDAapprved label Use this reference fr drug specific Onclgy agents fr yur review: es/medicaidhub7/ss/rx/mppa /PAguide/Onclgy%20Detaile d%20guidance%20dcuments. dcx

4 Antiemetic Agents: 5HT3 Receptr Blckers Preferred: Ondansetrn/ODT tablets, slutin Nn-preferred: Anzemet Akynze granisetrn Granisl sln/tab Kytril ndansetrn sln Sancus patch Zfran ODT/sln/tab Zuplenz film Cannabinids (delta- 9THC derivatives): Preferred: Drnabinl Nn-Preferred: Cesamet frmulary preferred agents Medical recrds, lab results, test results, and clinical markers supprting the diagnsis and treatment are submitted with the request Member des nt have any cntraindicatins t the medicatin Member is nt taking ther medicatins that shuld be avided with the requested drug based n the FDA-apprved labeling Request is nt fr experimental/investigatinal use r fr a clinical trial Diclegis(dxylamine/pyridxine): May be authrized when the fllwing criteria are met: Member is at least 18 years f age Diagnsis f nausea and vmiting in pregnancy Dcumentatin t supprt member had an inadequate respnse r intlerable side effects t dietary and lifestyle changes (e.g. aviding stimuli/triggers, aviding spicy and fatty fds, eating frequent small meals, an inadequate respnse t ginger) Member has had an inadequate respnse r intlerable side effects t: A cmbinatin f OTC dxylamine and OTC pyridxine (vitamin B6) AND at least 1 f the fllwing: H1 Antihistamines (e.g., diphenhydramine, meclizine, dimenhydrinate) OR Ondansetrn Clinical criteria fr 5HT3 Receptr Blckers: Nausea r vmiting related t radiatin therapy, mderate t highly emetgenic chemtherapy, r pst-perative nausea and vmiting; AND Patient has tried and failed therapeutic dses f, r has adverse effects r cntraindicatins t, 2 different cnventinal antiemetics (e.g., prmethazine, prchlrperazine, meclizine, metclpramide, dexamethasne, etc.) Apprval duratin fr 5HT3 Receptr Blckers : 3 mnths, unless therwise nted 3 mnths, unless therwise nted Patient is respnding t treatment Apprval duratin fr Cannabinids: Initial apprval: 6 mnths 6 mnths Patient is respnding t treatment Emend, Varubi: Length f chemtherapy regimen r a maximum f 6 mnths

5 Marinl NK-1 Receptr Antagnist: Emend Varubi AND General Nn-preferred guidelines Zfran ODT/sln/tab must meet nn-preferred medicatin guidelines nly. Cannabinids (delta-9thc derivatives): Clincial criteria fr Cesamet: Diagnsis f severe, chemtherapy induced nausea and vmiting, AND Patient has tried and failed, has a cntraindicatin t, an intlerance, r a medical reasn nt t try the cmbinatin f Emend plus a 5HT3 receptr antagnist plus a crticsterid; AND Patient has tried and failed megestrl acetate ral suspensin OR has a cntraindicatin, intlerance, drug-drug interactin, r medical reasn megestrl acetate cannt be used. Clinical criteria fr Drnabinl: Diagnsis f severe, chemtherapy induced nausea and vmiting, AND Patient has tried and failed, has a cntraindicatin t, an intlerance, r a medical reasn nt t try the cmbinatin f Emend plus a 5HT3 receptr antagnist plus a crticsterid; AND Diagnsis f AIDS-relating wasting AND Patient has tried and failed megestrl acetate ral suspensin OR has a cntraindicatin, intlerance, drug-drug interactin; OR has a Medical reasn megestrl acetate cannt be used. Marinl: Must meet clinical criteria fr Drnabinl and have trial f preferred Length f chemtherapy regimen r a maximum f 6 mnths Patient is respnding t treatment Diclegis: 1 year

6 cannabinid agent. NK-1 Receptr Antagnist: Emend Emend des NOT require treatment failure with preferred drugs when used fr mderately r highly emetgenic chemtherapy. Varubi Varubi des NOT require treatment failure with preferred drugs when used fr mderately r highly emetgenic chemtherapy. Indicated in cmbinatin with ther antiemetic agents in adults fr the preventin f delayed nausea and vmiting assciated with initial and repeat curses f emetgenic cancer chemtherapy, including, but nt limited t, highly emetgenic chemtherapy. Acne Agents, Tpical Fabir Fam ADHD (nnstimulants/stimulants) medicatins Clinical criteria fr Dermatlgic Acne agents: Patient is ver the age f 18 years AND Prducts are intended fr acne nly. Prir authrizatin fr a csmetic indicatin cannt be apprved. AND Had failure t respnd t a therapeutic trial f at least tw weeks f ne preferred drug. Fabir Fam Patient must be between the ages f 12 and 18 years f age AND Had failure t respnd t a therapeutic trial f at least tw weeks f ne preferred drug. Preferred stimulants/adhd medicatins fr individuals age 6-18 years d nt require prir authrizatin. Nn-preferred agents must meet age edit and nnpreferred clinical criteria fr apprval. FDA indicated age: Initial apprval: Patient is respnding t treatment Initial apprval:

7 Intuniv: > 4 years Immediate-release frmulatins (e.g., Ritalin, Methylin, Methylin chewable tablet/slutin, etc): > 3 years All ther agents(extended-release nce-daily prducts; e.g., Adderall XR, Metadate CD, Cncerta ; Ritalin, Fcalin XR, Strattera, Quillichew ER/susp, Aptensi XR, Adzenys XR ODT, Kapvay SR): > 6 years Patient is respnding t treatment Fr Brand Adderall XR : If a trial & failure f a preferred prduct ccurs and the physician requests Adderall XR r amphetamine salts cmb XR. The brand Adderall XR is preferred ver the generic. Fr Brand Kapvay SR: If a trial & failure f a preferred prduct ccurs and the physician requests Kapvay SR 12H r clnidine ER then Kapvay SR is preferred ver the generic clnidine ER. Age Edits clinical criteria fr ADHD mediatins: Children age less than 6 years f age: The medicatin is being prescribed by r in cnjunctin with a Psychiatrist, Neurlgist, Develpmental/Behaviral Pediatrician r a Pediatrician OR Primary care prvider has used the Diagnstic and Statistical Manual f Mental Disrders, 5 TH Editin and determined that criteria have been met (including dcumentatin f impairment in mre than 1 majr setting) t make the diagnsis f ADHD AND Primary care clinician use evidence-based parent and/r teacher-administered behavir therapy as the first line f treatment AND Patient has received a develpmentally-apprpriate,

8 cmprehensive ADHD assessment with diagnses, impairments, treatment target and treatment plans clearly identified and has been dcumented Adults age 18 and lder: Patient has a diagnsis f ADHD/ADD, narclepsy, idipathic hypersmnia, r fatigue related t cancer r multiple sclersis AND The medicatin is being prescribed by r in cnjunctin with a Psychiatrist, Neurlgist, Develpmental/Behaviral Pediatrician r a Pediatrician OR Primary care prvider has used the Diagnstic and Statistical Manual f Mental Disrders, 5 TH Editin and determined that criteria have been met (including dcumentatin f impairment in mre than 1 majr setting) t make the diagnsis f ADHD In additin clinical criteria fr nn-preferred agents: Must meet general nn-preferred guideline Had failure t respnd t a therapeutic trial f at least ne preferred drug. Ampyra The patient has a diagnsis f Multiple Sclersis and a gait disrder, AND Patient has n histry f seizures; AND Patient s Creatinine Clearance [CrCL] 50 ml/min Initial apprval: 2 mnths Patient must shw imprvement r that the drug was effective (by imprved Timed 25-ft Walk)

9 Analgesics Opiids Lng/Shrt- Acting All schedule II and III piate narctics except Fentanyl Transmucsal Prducts, methadne Tramadl Pentazcine All piids will be subject t a >/= 120 cumulative mrphine milligram equivalent per day edit. This may require additinal medical necessity. Prescribers shall rder nalxne fr any patient with risk factrs f prir verdse, substance use disrder, daily mrphine equivalent exceeding 120 mg, r cncmitant benzdiazepines per Virginia BOM regulatins. The General Authrizatin criteria is nt required fr members with intractable pain assciated with active cancer, r in remissin with a tapering plan, palliative care, hspice, r in a lng-term care setting. Additinal Prir Authrizatin criteria will still be required fr xymrphne ER, nn-preferred lng acting piids and nn-preferred shrt acting piids. General Authrizatin Criteria fr ALL piids: Prescriber agrees t ALL f the fllwing: Prescriber has checked the Virginia Prescriptin Mnitring Prgram (PMP);PMP website: Ensures member is within piid dsing limits and verifies cncmitant treatment with benzdiazepines Dcuments the MME/day and date f last piid and benzdiazepine filled (members in a Lng Term Care are excluded frm this requirement) Prescriber must agree t the fllwing fr histry f benzdiazepine filled within the past 30 days;: Cunseled member n the FDA black bx warning n the dangers f prescribing piids and benzdiazepines including fatal verdse Dcumented that treatment is medically necessary and has recrded a tapering plan t achieve the lwest pssible 1 mnth fr pst-p pain 6 mnths fr chrnic pain Renewals: 1 mnth fr pst-p pain 6 mnths fr chrnic pain Prescriber has reviewed and dcumented infrmatin required frm PMP UDS results (see criteria fr specific requirements) Opiid_Quantity_Limits Opiid Quantity Limit List.dcx

10 effective dse f bth piids and benzdiazepines per the Virginia Bard f Medicine Opiid Prescribing Regulatins dsbuprenphine_ dc Fr chrnic pain, the prescriber attests that a treatment plan with gals that addresses benefits and harm has been established with the patient The treatment plan is reviewed with the patient within 1 t 4 weeks f starting piid therapy fr chrnic pain and with any dse escalatin The treatment plan is reviewed every 3 mnths r mre frequently The fllwing items must be included in the treatment plan: Established expected utcme and imprvement in bth pain relief and functin r just pain relief as well as limitatins (e.g., functin may imprve yet pain persist OR pain may never be ttally eliminated) Established gals fr mnitring prgress tward patient-centered functinal gals (e.g., walking the dg r walking arund the blck, returning t part-time wrk, attending family sprts r recreatinal activities, etc.) Gals fr pain and functin, hw piid therapy will be evaluated fr effectiveness and the ptential need t discntinue if nt effective Emphasis n serius adverse effects f piids (including fatal respiratry depressin, piid use disrder, r altered ability t safely perate a vehicle) Emphasis n cmmn side effects f piids (e.g., cnstipatin, dry muth, nausea, vmiting, drwsiness, cnfusin, tlerance, physical dependence, r withdrawal)

11 There is a SIGNED AGREEMENT with the patient. A sample Physician/Patient Agreement may be fund at: mentfrms.pdf Fr chrnic pain, the prescriber must have rdered and reviewed a urine drug screen (UDS) r serum medicatin level prir t initiating treatment with shrt acting piids and/r lng acting piids. Fr PA renewals, the prescriber must have rdered and reviewed a UDS r serum medicatin level every 3 mnths fr the first year, and every 6 mnths thereafter t ensure adherence The prescriber has used at least ne nn-piid therapy prir t cnsideratin f an piid (e.g., NSAID s, diclfenac gel 1 %, dulxetine, gabapentin, r baclfen) Additinal Prir Authrizatin Criteria: Lng Acting Opiids Dcumentatin t supprt member meets the fllwing: Diagnsis f ne f the fllwing: Intractable pain assciated with active cancer Member is in remissin with a plan t taper Member is in palliative care, hspice, r a lng-term care facility r Diagnsis f chrnic pain r pst-perative pain and Member has tried at least ne nn-piid agent (e.g., NSAID s, diclfenac gel 1 %, dulxetine, gabapentin, r baclfen) Fr Oxymrphne ER Dcumentatin t supprt an adequate 2 week trial and failure f TWO frmulary alternatives (i.e., buprenrphine

12 patch, fentanyl patch, r mrphine sulfate ER) r cntraindicatin t all f the agents Fr nn-preferred lng acting piids Dcumentatin t supprt an adequate 2 week trial and failure f TWO preferred frmulary alternatives (i.e., Oxymrphne ER, buprenrphine patch, fentanyl patch, r mrphine sulfate ER) r cntraindicatin t all f the agents Shrt-Acting Opiids Initial prescriptins fr schedule II and III shrt-acting piate cntaining medicatins will be allwed, up t a 7-day supply, withut prir authrizatin. The member will be allwed ne additinal 7-day supply within 60 days f the riginal prescriptin fill date. Any additinal prescriptins within 60 days frm the fill date f the riginal prescriptin will require prir authrizatin. Dcumentatin t supprt member meets all f the fllwing: Diagnsis f ne f the fllwing: Intractable pain assciated with active cancer, Member is in remissin with a plan t taper Member is in palliative care, hspice r a lng-term care facility r Diagnsis f chrnic pain r pst-perative pain and Member has tried at least ne nn-piid agent (e.g., NSAID s, diclfenac gel 1 %, dulxetine, gabapentin, r baclfen) Fr nn-preferred shrt acting piids: Dcumentatin t supprt an adequate 2 week trial and failure f TWO preferred shrt acting piids r cntraindicatin t all f the frmulary shrt acting piids

13 Methadne All piids will be subject t a >/= 120 cumulative mrphine milligram equivalent per day edit. This may require additinal medical necessity. Prescribers shall rder nalxne fr any patient with risk factrs f prir verdse, substance use disrder, daily mrphine equivalent exceeding 120 mg, r cncmitant benzdiazepines per Virginia BOM regulatins. General Authrizatin Criteria: Prescriber agrees t ALL f the fllwing: Prescribed by ne f the fllwing specialists- nclgist, sickle cell specialist, chrnic pain specialist, r palliative care Prescriber has checked the Virginia Prescriptin Mnitring Prgram (PMP) n the date f the request PMP website: gin.aspx Dcuments the MME/day and date f last piid and benzdiazepine filled (members in a Lng Term Care are excluded frm this requirement) prescriber must agree t the fllwing fr histry f benzdiazepine filled within the past 30 days; Cunseled member n the FDA black bx warning n the dangers f prescribing piids and benzdiazepines including fatal verdse Dcumented that treatment is medically necessary The treatment plan is reviewed with the patient within 1 t 4 weeks f starting piid therapy fr chrnic pain and with any dse escalatin. The treatment plan is reviewed every 3 mnths r mre frequently. The fllwing items must be included in the treatment plan: Established expected utcme and imprvement in bth pain relief and functin r just pain relief as well as 6 mnths fr chrnic pain Up t 1 years f age fr infants discharged n methadne Renewals: 6 mnths fr chrnic pain Prescriber has reviewed and dcumented infrmatin required frm PMP UDS results (see criteria fr specific requirements)

14 limitatins (e.g., functin may imprve yet pain persist OR pain may never be ttally eliminated) Established gals fr mnitring prgress tward patient-centered functinal gals (e.g., walking the dg r walking arund the blck, returning t part-time wrk, attending family sprts r recreatinal activities, etc.) Gals fr pain and functin, hw piid therapy will be evaluated fr effectiveness and the ptential need t discntinue if nt effective Emphasis n serius adverse effects f piids (including fatal respiratry depressin, piid use disrder, r altered ability t safely perate a vehicle) Emphasis n cmmn side effects f piids (e.g., cnstipatin, dry muth, nausea, vmiting, drwsiness, cnfusin, tlerance, physical dependence, rwithdrawal) There is a SIGNED AGREEMENT with the patient. A sample Physician/Patient Agreement may be fund at: ntfrms.pdf A presumptive urine drug screen (UDS) MUST be dne at least annually. The UDS must check fr the prescribed drug plus a minimum f 10 substances including herin, prescriptin piids, ccaine, marijuana, benzdiazepines, amphetamines, and metablites. A cpy f the mst recent UDS must be submitted with the fax frm. Member des nt have a histry f, r received treatment fr, drug dependency r drug abuse Dcumentatin t supprt an adequate 2 week trial and failure f ALL preferred frmulary alternatives (i.e., Oxymrphne ER, buprenrphine patch, fentanyl patch, and mrphine sulfate ER) r

15 cntraindicatin t all f the agents Nte: methadne will nly be apprved in children discharged frm the hspital (up t 1 year f age) and fr thse requiring arund the clck analgesia i.e. chrnic pain. Methadne is nt cvered under the pharmacy benefit fr the treatment f piid addictin. Transmucsal Immediate Release Fentanyl (TIRF) Agents i Abstral (fentanyl) sublingual tablets fentanyl citrate lzenge Fentra (fentanyl) buccal tablets Lazanda (fentanyl citrate) nasal spray Subsys (fentanyl) sublingual spray TIRF agents are piid analgesics that are apprved fr the management f breakthrugh cancer pain in patients wh are receiving and are tlerant t piid therapy fr underlying persistent cancer pain. TIRF agents are available nly thrugh a restricted TIRF REMS Access prgram. The preferred frmulary prduct is the generic fentanyl citrate with PA. May be authrized fr members when all f the fllwing criteria are met: Member is at least 16 years ld (fr Actiq r generic fentanyl citrate lzenge) and at least 18 years ld (fr Abstral, Fentra, Lazanda, and Subsys) Prescribed by, r in cnsultatin with, an nclgist r pain specialist Dcumentatin t supprt diagnsis f cancer and that treatment will be used fr breakthrugh cancer pain Member is n a lng-acting piid arund-the-clck fr treatment f cancer pain Members must be cnsidered piid-tlerant and are cnsidered piid-tlerant if they have received at least ne week f treatment n ne f the fllwing medicatins: Mrphine sulfate at dses f at least 60 mg/day Fentanyl transdermal patch at dses f at least 25 mcg/hur Oxycdne at dses f at least 30 mg/day AND Oral hydrmrphne at dses f at least 8 mg/day An alternative piid at an equianalgesic dse fr at least a week (e.g., ral methadne at dses f at least 20 mg/day) 6 mnths Renewals: 1 year Dcumented imprvement in breakthrugh cancer pain Cntinued use f a lng-acting piid arund-the-clck while n treatment QLL: Abstral: 4 tablets/day Actiq: 4 lzenges/day Fentra: 4 tablets/day Lazanda: 1 bttle/day Subsys: 4 sprays/day

16 Fr all ther nn-frmulary agents, member had inadequate respnse r intlerable side effects with generic fentanyl citrate lzenge. **NOTE: TIRFs are nt cvered fr the management f acute r pstperative pain including migraine headaches r fr members wh are nt tlerant t piids and wh are nt currently n piid therapy. ARBs ii Antidepressants Nn- Preferred iii Nn-preferred ARBs may be apprved fr members wh have meet all f the fllwing: Diagnsis is fr an FDA apprved indicatin Member had inadequate trial and failure r intlerance t 3 frmulary preferred ARBs Member may be apprved as cntinuity f care if the patient is currently stable n the requested nn-preferred antidepressant. General Criteria fr all new starts: Member is 18 years f age r lder (except fr fluvxamine and fluxetine) Requested agent is FDA-apprved fr the indicatin being treated If there is a frmulary preferred agent available in a different frmulatin f the same ingredient (e.g., Pexeva, Aplenzin, Frfiv XL, fluvxamine ER, parxetine mesylate, fluxetine weekly), the patient must have a dcumented trial and failure f that frmulary agent Additinal criteria based n indicatin: Majr Depressive Disrder r Seasnal Affective Disrder: Member has had dcumented failure f, r intlerance t 3frmulary agents frm at least 2 different classes f antidepressants (SSRI, SNRI, buprpin, r mirtazapine) at an adequate dse and duratin (at least 4 weeks); OR Initial apprval: Indefinite Initial apprval: Indefinite

17 Member has had dcumented failure f, r intlerance t TWO frmulary agents AND an acceptable antidepressant augmentatin regimen (SSRI r SNRI plus ne f the fllwing: buprpin, lithium, atypical antipsychtic, buspirne, r lithyrnine) at an adequate dse and duratin (at least 4 weeks) One f these trials must be with a preferred frmulary agent frm the same class (SSRI r SNRI) Obsessive-Cmpulsive Disrder: Member has had dcumented failure f, r intlerance t 3 frmulary agents (e.g., SSRI s, clmipramine) at an adequate dse and duratin (at least 4 weeks). Panic Disrder r Generalized Anxiety Disrder: Member has had had dcumented failure f, r intlerance t 3 frmulary agents frm at least 2 different classes f antidepressants (e.g., SSRI s r SNRI s) at an adequate dse and duratin (at least 4 weeks). Ht Flashes Assciated with Menpause: Member has had had dcumented failure f, r intlerance t 3 frmulary agents frm at least 2 different classes f antidepressants (e.g., SSRI s r SNRI s) at an adequate dse and duratin (at least 4 weeks). Trial and failure f, intlerance t, r patient preference t avid hrmnal therapy Buprenrphine prducts Authrizatin Criteria fr INITIAL Treatment (during the first 3 mnths): Patient is at least 16 years f age and diagnsed with Opiid Use Disrder using DSM 5: cntent/uplads/2014/02/5b-dsm-5-opiid-use-disrder-diagnstic- Criteria.pdf Prescriber cnfirms the patient is participating in psychscial cunseling (individual r grup) at least nce per week. Initial apprval: 3 mnths 6 mnths 10 mnths maximum duratin fr plain buprenrphine fr pregnancy

18 Prvider pssesses a DATA2000 waiver t prescribe medicatin-assisted piid dependency treatment and has a DEA assigned X number. Prescriber has reviewed the Virginia Prescriptin Mnitring Prgram (PMP) prir t initiatin f buprenrphine and dcuments date f last piid and benzdiazepine prescriptin. Patient is nt taking carisprdl, sedative hypntics, tramadl, ther piates, r benzdiazepines cncurrently with buprenrphine. Due t a higher risk f fatal verdse with cncmitant use f these drugs, the prescriber shall nly c-prescribe these substances when there are extenuating circumstances and shall dcument in the medical recrd a tapering plan t achieve the lwest pssible effective dses f these medicatins. Prescriber has a dcumented tapering plan. renphine_ dc In additin fr Subxne Film, Zubzlv, r Bunavail: a MedWatch frm must be submitted with request detailing treatment failure with 2 different manufacturers f buprenrphine/nalxne tablets. FDA MedWatch Frm Dcumentatin required: Frequency f psychscial cunseling Prescriber has reviewed and dcumented infrmatin required frm PMP Attestatin f cncmitant therapies UDS results (see criteria fr specific requirements) In additin fr plain buprenrphine mntherapy (withut nalxne): Patient must be pregnant and a psitive pregnancy test must be submitted with request. Authrizatin Criteria fr MAINTENANCE Treatment (after the first 3 mnths): Prescriber cnfirms the patient is participating in psychscial cunseling (individual r grup) at least nce per mnth. Prescriber has reviewed the Virginia Prescriptin Mnitring Prgram (PMP) n the date f the request. Patient is nt taking carisprdl, sedative hypntics, tramadl, ther

19 Cialis fr Benign Prstatic Hypertrphy (BPH) piates, r benzdiazepines. Due t a higher risk f fatal verdse with cncmitant use f these drugs, the prescriber shall nly c-prescribe these substances when there are extenuating circumstances and shall dcument in the medical recrd a tapering plan t achieve the lwest pssible effective dses f these medicatins. Prescriber has a dcumented tapering plan. renphine_ dc Randm urine drug screens (UDS) were cmpleted 4 times in the past 6 mnths, UDS must check fr buprenrphine, nrbuprenrphine, methadne, xycdne, benzdiazepines, amphetamine/methamphetamine, ccaine, herin, THC, and ther prescriptin piates. The mst recent 2 UDS results (with at least 1 UDS in the past mnth) are submitted with request. If a drug screen is negative fr buprenrphine/nrbuprenrphine and/r psitive fr anther substance, written dcumentatin is required utlining steps taken t address patient s pssible diversin f buprenrphine and/r nging use f ther substances. This may include intensifying the cunseling that patient is receiving and/r cnsidering referral t higher level f care (such as intensive utpatient, partial hspitalizatin, r residential treatment). The buprenrphine dse des nt exceed 16 mg/day. Dses greater than 24 mg/day will nt be apprved. Clinical criteria fr Cialis 2.5mg and 5mg: Patient must try and fail (r have cntraindicatins) t bth Alpha Blckers (e.g. alfuzsin, tamsulsin) and Andrgen Inhibitrs (e.g. finasteride) fr BPH and The prescriber must attest that the patient is nt n the state list f sex ffenders and

20 The patient must have had a cnsult r been evaluated by an Urlgist. Patient is respnding t treatment Clny-Stimulating Factrs (CSF) Neupgen, Neulasta, Zarxi, Granix, Leukine General Authrizatin Criteria fr ALL Agents and Indicatins: Prescribed by, r in cnsultatin with, a hematlgist r nclgist Medical recrds, including labs and weight r BSA, t supprt diagnsis and dsing is submitted with request Requested agent is dsed and administered within FDA labeled recmmendatins Will nt be used cncmitantly with radiatin Will be administered at the apprpriate time after chemtherapy Patient des nt have any cntraindicatins t the requested agent Leukine- patients with excessive leukemic blasts ( 10%) in the bne marrw r peripheral bld) Neupgen/Zarxi- E-Cli hypersensitivity Will nt be used in cmbinatin with ther myelid grwth factrs Additinal Criteria Based n Indicatin: Chemtherapy-Induced Febrile Neutrpenia: (Neupgen, Neulasta, Granix, an d Zarxi) Patient is receiving chemtherapy fr a NON-myelid cancer (i.e., slid tumr, lymphma) Fr PRIMARY prphylaxis: Patient meets ONE f the fllwing: Chemtherapy regimen is given after bne marrw transplant; OR Chemtherapy regimen has >20% risk f febrile neutrpenia; OR Chemtherapy regimen has 10%-20% risk f febrile neutrpenia AND patient has ANY f the Chemtherapy-induced neutrpenia (primary r secndary prphylaxis): Apprve per cycle f chemtherapy: Up t a 14 day supply fr Neupgen, Zarxi, Granix, and Leukine ne (1) 6 mg dse f Neulasta Include refills if number f cycles is prvided Treatment f neutrpenia (e.g., cngenital, cyclic, r idipathic, HIV, r after chem + BMT): Apprve fr 3 mnths Fr ther indicatins Up t 6 mnths r less Chemtherapy-induced neutrpenia (primary r secndary prphylaxis): Aetna standard guideline

21 fllwing risk factrs fr febrile neutrpenia: age > 65 years prir chemtherapy r radiatin therapy persistent neutrpenia bne marrw invlvement by tumr Recent surgery and r pen wunds Liver dysfunctin (bilirubin > 2.0) Renal dysfunctin (CRCL <50) HIV Fr SECONDARY pr phylaxis: Patient previusly experienced febrile neutrpenia frm the same chemtherapy regimen and reducing r delaying chemtherapy dse may cmprmise treatment utcme Fr TREATMENT f febrile neutrpenia in patients wh did NOT receive CSF s prphylaxis: Patient has risk factrs fr pr utcmes resulting frm febrile neutrpenia (e.g., age > 65, sepsis, severe neutrpenia (ANC< 100/mcL), current infectin, hspitalized at nset f fever, prir episde f febrile neutrpenia) Severe chrnic cngenital neutrpenia, cyclic neutrpenia, r idipathic neutrpenia: (Zarxi, Neupgen) Patient has ONE f the fllwing: Evidence f inadequate bne marrw reserve (e.g., recurrent fevers, splenmegaly, mucsal ulcers, abdminal pain) High risk fr develping serius bacterial infectin (e.g., primarily severe neutrpenia, indwelling venus catheters, prir serius infectins) Current bacterial infectin Neutrpenia related t HIV: (Zarxi, Neupgen) Patient is taking antiretrviral therapy regimen that des NOT cntain zidvudine Patient is NOT taking Recent ANC shwing a respnse t therapy Apprve per cycle f chemtherapy: Up t a 14 day supply fr Neupgen, Zarxi, Granix and Leukine ne (1) 6 mg dse f Neulasta Include refills if number f cycles is prvided All ther indicatins: Recent ANC, CBC, and/r platelet cunts Apprve up t 1 year r less, depending n the indicatin

22 sulfamethaxazle/trimethprim. NOTE: Patients wh require pneumcystis prphylaxis shuld be switched t atvaqune r dapsne (unless cntraindicated) Patient has ONE f the fllwing: Evidence f inadequate bne marrw reserve (e.g., recurrent fevers, splenmegaly, mucsal ulcers, abdminal pain) High risk fr develping serius bacterial infectin (e.g., primarily severe neutrpenia, indwelling venus catheters, prir serius infectins) Patient has a dcumented bacterial infectin Neupgen and Zarxi may als be apprved if medically necessary fr the fllwing indicatins: Acute Myelid Leukemia in patients receiving inductin r cnslidatin chemtherapy Mbilizatin f hematpietic prgenitr cells befre autlgus stem cell transplant Mbilizatin f hematpietic prgenitr cells in the dnr befre allgenic stem cell transplant Treatment f acute radiatin expsure in patients wh receive myelsuppressive dses f radiatin at a dse f 2 gray (Gy) Myeldysplastic Syndrme (MDS) r aplastic anemia in a patient with an ANC <500 Leukine may als be apprved if medically necessary fr the fllwing indicatins: Acute Myelid Leukemia after inductin chemtherapy fr patients age 55 years r lder Bne marrw transplant failure r engraftment delay Myelid recnstitutin after allgenic bne marrw transplant

23 Myelid recnstitutin after autlgus bne marrw transplant in patients with Hdgkin s disease, nn-hdgkin s lymphma, r acute lymphcytic leukemia. Befre and after autlgus peripheral bld stem cell transplantatin Nn-preferred Nnpreferred teststerne Agents Anti-Allergens: Grastek Oralair Ragwitek Clinical criteria fr teststerne agents: Must meet general nn-preferred guideline: Had failure t respnd t a therapeutic trial f at least tw weeks f ne preferred drug. Clinical Criteria fr Grastek Age must be between 5 thrugh 65 years, AND Indicated fr grass pllen-induced allergic rhinitis with r withut cnjunctivitis; AND Must have evidence f a cnfirmed by psitive skin test r in vitr testing fr pllen-specific IgE antibdies fr Timthy grass r crssreactive grass pllens; AND Must have had a treatment failure with r cntraindicatin t antihistamines and mntelukast; AND Clinical reasn as t why allergy shts cannt be used. Quantity Limit = 1 sublingual tablet per day. Clinical Criteria fr Oralair Age must be between 10 thrugh 65 years; AND Indicated fr grass pllen-induced allergic rhinitis with r withut cnjunctivitis; AND Must have evidence f a cnfirmed psitive skin test r in vitr testing Patient is respnding t treatment Patient is respnding t treatment

24 fr pllen- specific IgE antibdies fr Sweet Vernal, Orchard, Perennial Rye, Timthy, and Kentucky Blue Grass Mixed Pllens; AND Must have had a treatment failure with r cntraindicatin t antihistamines and mntelukast, AND Clinical reasn as t why allergy shts cannt be used. Nn-preferred Antibitics Cephalsprins Macrlides Quinlnes Clinical Criteria fr Ragwitek Age must be between 18 thrugh 65 years; AND Indicated fr immuntherapy fr the treatment f shrt ragweed plleninduced allergic rhinitis, with r withut cnjunctivitis; AND Must have evidence f a cnfirmed by psitive skin test r in vitr testing fr pllen-specific IgE antibdies fr shrt ragweed pllen; AND Must have had a treatment failure with r cntraindicatin t antihistamines and mntelukast; AND Clinical reasn as t why allergy shts cannt be used Clinical Criteria fr Cephalsprins, Macrlides, Quinlnes: Infectin caused by an rganism resistant t preferred drugs, OR A therapeutic failure t n less than a three-day trial f ne preferred drug within the same class; OR The patient is cmpleting a curse f therapy with a nn-preferred drug which was initiated in the hspital. Apprval duratin: Date f service nly; n refills. Antihyperuracemics - Clcrys Clinical criteria fr Clcrys: Diagnsis f Familial Mediterranean Fever; OR Acute Gut Flare: Trial and failure f ne f the fllwing: NSAID r Crticsterid AND Had failure t respnd t a therapeutic trial f at least ne preferred drug. Apprval duratin: 1 year

25 Antipsychtics In Children Less Than 18 Years Celecxib Clinical criteria fr antipsychtics in children less than 18 years f age: Prir authrizatin is required fr all agents when prescribed fr patients wh are under 18 years f age (typical and atypical antipsychtic agents): Antipsychtic is being prescribed by, r in cnsultatin with a Psychiatrist, Neurlgist, r a Develpmental/Behaviral Pediatrician. Dcumentatin f a develpmentally-apprpriate, cmprehensive psychiatric assessment with diagnses, impairments, treatment target and treatment plans has been dne. Patient had inadequate clinical respnse t a psychscial treatment and psychscial treatment with parental invlvement will cntinue fr the duratin f medicatin therapy. Parent r guardian infrmed cnsent has been btained fr this medicatin. A family assessment has been dne and includes parental psychpathlgy and treatment needs and evaluatin fr family functining and parent-child relatinship. In additin clinical criteria fr nn-preferred agents: Must meet general nn-preferred guideline Had failure t respnd t a therapeutic trial f at least ne preferred drug. Clinical Criteria fr celecxib: Histry f a trial f a minimum f tw (2) different nn-cox2 NSAIDs within the past year; OR Cncurrent use f anticagulants (i.e., warfarin, heparin, etc.), methtrexate, ral crticsterids; OR Histry f previus GI bleed r cnditins assciated with GI txicity risk factrs (i.e., PUD, GERD, etc.); OR Specific indicatin fr celecxib, which preferred drugs are nt indicated. Patient is respnding t treatment Patient is respnding t treatment

26 Cugh and Cld Prducts Cytkine and CAM Antagnists And Related Agents Preferred: Humira Enbrel Clinical Edit fr Cugh and Cld Agents Patient is 6 years f age and lder; AND Had failure t respnd t a therapeutic trial f at least ne preferred drug. Nte: Children under the age f 6 years are nt eligible fr cugh and cld prducts. Enbrel and Humira are preferred agents withut PA. Nn-preferred agents must meet drug specific criteria and general nn-preferred criteria fr apprval. Clinical criteria fr Cimzia: Diagnsis f Mderately t severely active Crhn s Disease in adult members; AND Trial and failure f a cmpliant regimen f ral crticsterids (mderate t severe CD) unless cntraindicated r intravenus crticsterids (severe and fulminant CD r failure t respnd t ral crticsterids), AND Trial and failure f a cmpliant regimen f azathiprine r mercaptpurine fr three cnsecutive mnths, AND Trial and failure f a cmpliant regimen f parenteral methtrexate fr three cnsecutive mnths Diagnsis Mderately t severely active RA in cmbinatin with methtrexate; AND Trial and failure f, cntraindicatin, r adverse reactin t methtrexate and at least ne ther DMARD (sulfasalzine, hydrxychlrquine, mincycline) Diagnsis f Psriatic arthritis, Ankylsing spndylitis; AND Had trial and failure t f at least ne preferred drug Apprval duratin: 1 time (date f service) Initial: 3 mnths fr Crhn s r Ulcerative Clitis; 1 year fr all ther indicatins. 1 year dependent upn medical recrds supprting respnse t therapy and review f Rx histry. Rasuv/Otrexup: Initial: RA: 6 mnths Psriasis: 6 mnths Quantity Limit = 4 aut-injectrs per mnth Fr renewal: Patient must be fllwed by a physician fr mnitring f renal and hepatic functin and cmplete bld cunts with differential and platelet cunt. RA: 1 year Psriasis: 6 mnths

27 Clinical criteria fr Csentyx (secukinumab): Diagnsis f Mderate t severe Plaque Psriasis Must have a previus failure n a tpical psriasis agent Clinical criteria fr Kineret (anakinra): Diagnsis Mderately t severely active RA; AND Trial and failure f, cntraindicatin, r adverse reactin t methtrexate and at least ne ther DMARD (sulfasalzine, hydrxychlrquine, mincycline) Diagnsis f Crypyrin-Assciated Peridic Syndrmes (CAPS); AND Apprvable with cnfirmatin f this diagnsis. Clinical criteria fr Orencia (abatacept): Mderately t severely active RA Trial and failure f, cntraindicatin, r adverse reactin t methtrexate and at least ne ther DMARD (sulfasalzine, hydrxychlrquine, mincycline) Juvenile Idipathic Arthritis (JIA) in members 6 years and lder Had trial and failure t f at least ne preferred drug Clinical criteria fr Otezla (apremilast): Diagnsis f Mderate t severe Plaque Psriasis Must have a previus failure n a tpical psriasis agent Diagnsis f Active psriatic arthritis Had trial and failure t f at least ne preferred drug Clinical criteria fr Otrexup: Diagnsis f active rheumatid arthritis (RA) r plyarticular juvenile idipathic arthritis (pjia) Member had therapeutic failure t methtrexate Patient des nt require any f the fllwing methtrexate regimens: Dses less than 10 mg per week Dses abve 25mg per week High dse regimens, r

28 Dse adjustments less than 5mg increments Clinical criteria fr Rasuv (methtrexate): Diagnsis f rheumatid arthritis r plyarticular juvenile idipathic arthritis, AND A therapeutic trial and failure n NSAIDs and/r crticsterids t reduce jint inflammatin, OR The patient is nt a candidate fr these therapies due t disease severity. Diagnsis f psriasis, AND A therapeutic trial and failure n tpical therapies such as tpical emllients and/r tpical crticsterids, tpical retinids, tpical vitamin D analgs, and tpical tacrlimus AND pimecrlimus. Clinical criteria fr Simpni (glimumab): Diagnsis f Mderately t severely active Rheumatid Arthritis (RA) in adults, in cmbinatin with methtrexate Trial and failure f, cntraindicatin, r adverse reactin t methtrexate alne and at least ne ther DMARD (sulfasalzine, hydrxychlrquine, mincycline). Must be in cmbinatin with methtrexate. Diagnsis f Active Psriatic Arthritis (PsA) in adults, alne r in cmbinatin with methtrexate, Active Ankylsing Spndylitis in adults (AS) Had trial and failure t f at least ne preferred drug Diagnsis f Mderately t severely active Ulcerative Clitis Trial and failure f a cmpliant regimen f ral r rectal aminsalicylates (i.e., sulfasalazine r mesalamine) fr tw cnsecutive mnths, AND Trial and failure f a cmpliant regimen f ral crticsterids (fr mderate t severe CD) unless cntraindicated, r intravenus crticsterids (fr severe and fulminant CD r failure t respnd t ral crticsterids), AND Trial and failure f a cmpliant regimen f azathiprine r mercaptpurine fr three cnsecutive mnths Clinical criteria fr Stelara (ustekinumab):

29 Diagnsis f Mderate t severe Plaque Psriasis Must have a previus failure n a tpical psriasis agent Diagnsis f Psriatic arthritis Had trial and failure t f at least ne preferred drug Clinical criteria Taltz: Fr the treatment f adults with mderate-t-severe plaque psriasis wh are candidates fr systemic therapy r phttherapy. Must have a previus failure n a tpical psriasis agent Minimum age restrictin f 18 years f age. Clinical criteria fr Xeljanz: Diagnsis f mderate t severe active rheumatid arthritis Member had an inadequate respnse t r intlerance t methtrexate AND Member had a therapeutic trial and failure with Enbrel r Humira Patient is currently nt using any bilgic DMARDs r ptent immunsuppresants (i.e. azathiprine, cyclsprine) Daliresp Clinical Criteria fr Daliresp If the patient has a diagnsis f severe COPD assciated with chrnic brnchitis and a histry f exacerbatins; AND Trial/failure n at least ne first-line r secnd-line agent (inhaled antichlinergics, lng acting beta agnists r inhaled crticsterids); AND Adjunctive therapy (Daliresp must be used in cnjunctin with firstline r secnd-line agent). Patient is respnding t treatment Diabetic Testing Supplies Diabetic Test Strip and Glucmeter Quantity Limits: All diabetic test strips are limited t 150ct/30 days 1 year

30 Direct Renin Inhibitrs iv Tekturna Tekturna HCT Tekaml Glucmeters are limited t 1 glucmeter/12 mnths Criteria t Receive Nn-Frmulary Diabetic Supplies Member with hematcrit level that is chrnically less than 30% r greater than 55% Accu-Chek Aviva Plus and Nan SmartView are accurate fr Hct 10-65% One Tuch Veri IQ is accurate fr Hct 20-60% Member with physical limitatin (manual dexterity r visual impairment) that limits utilizatin f frmulary prduct Member with an insulin pump that requires a specific test strip Criteria t Receive >150 Test Strips Per Mnth Members newly diagnsed with diabetes r with gestatinal diabetes Children with diabetes (age 12 ) Members n insulin pump Members n high intensity insulin therapy with dcumentatin f need t rutinely test mre than 4-5 times daily Criteria t Receive >1 Glucmeter Per Year Current glucmeter is unsafe, inaccurate, r n lnger apprpriate based n patients medical cnditin Current glucmeter n lnger functins prperly, has been damaged, r was lst r stlen. May be authrized when all f the fllwing criteria are met: Member is 18 years f age r lder Diagnsis f Hypertensin (HTN) Dcumented trial and failure r cntraindicatin t 2 frmulary alternatives; an Angitensn Receptr Blcker (ARB) r an ACE inhibitr Will nt be used in cmbinatin with an ACE inhibitr r an ARB Indefinite Elidel-Tacrlimus Clinical Criteria fr Elidel and tacrlimus

31 Dupixent v Elidel: Patient must have a FDA apprved diagnsis: Atpic dermatitis Elidel: mild t mderate fr ages > 2 years AND Failure t tpical crticsterids (i.e., desnide, fluticasne prpinate, hydrcrtisne butyrate, etc.) Tacrlimus: Patient must have a FDA apprved diagnsis: Atpic dermatitis tacrlimus 0.03%: mderate t severe fr ages > 2 years. tacrlimus 0.1%: mderate t severe fr ages > 18 years; AND Failure t tpical crticsterids (i.e., desnide, fluticasne prpinate, hydrcrtisne butyrate, etc.) May be authrized when all f the fllwing criteria is met: Member is at least 18 years f age Diagnsis f mderate t severe atpic dermatitis Prescribed by, r in cnsultatin with, a dermatlgist, allergist r immunlgist Patient had an inadequate respnse r intlerable side effects t ALL f the fllwing: Tw preferred (medium t very high ptency) tpical crticsterids (e.g. triamcinlne, clbetasl, mmetasne, betamethasne, flucinnide) One tpical calcineurin inhibitrs (e.g., tacrlimus) Patient is respnding t treatment 4 mnths Renewals: 6 mnths Cmpliance and adherence t treatment At least 20% symptm imprvement (e.g., reductin in lesins) r Investr s Static Glbal Assessment (ISGA) f 0 r 1 clear r almst clear Dsing: Initial: 600 mg SQ Maintenance: 300 mg SQ every 2 weeks

32 Enstilar Fam Eucrisa vi Clinical Criteria fr Enstilar Fam: Diagnsis f plaque psriasis; AND Minimum age f 18 years; AND Requires a therapeutic failure t at least a tw-week trial f the preferred drug within the same class. May be authrized when all f the fllwing criteria is met: Member is at least 2 years f age Diagnsis f mild t mderate atpic dermatitis Prescribed by, r in cnsultatin with, a dermatlgist, allergist r immunlgist Member had an inadequate respnse r intlerable side effects t ALL f the fllwing: Tw preferred (medium ptency) tpical crticsterids (e.g. hydrcrtisne, triamcinlne, mmetasne, betamethasne, fluticasne) One tpical calcineurin inhibitrs (e.g., tacrlimus) 4 weeks 4 weeks 4 weeks Renewals: 3 mnths Imprvement in lesins Cmpliance and adherence t treatment Investr s Static Glbal Assessment (ISGA) f 0 r 1 clear r almst clear r at least 20% symptm imprvement (e.g., reductin in lesins) Nn-preferred Antihypertensives, Sympathlytics Clinical criteria fr sympathlytics: Must meet general nn-preferred guideline: Had failure t respnd t a therapeutic trial f at least TWO preferred drug (s) within the same Quantity Limit: 60 gm tube per mnth 100 gm tube per mnth 1 year

33 Catapres Clnidine(transdermal) Clrpres Methyldepa/HCTZ Tenex Hemangel Entrest Frte (teriparatide) class. Clinical criteria fr Hemangel: Diagnsis treatment f prliferating infantile hemangima requiring systemic therapy; AND Patient s age must be between 5weeks and 5 mnths. Clinical criteria fr Entrest: Diagnsis f chrnic heart failure (NYHA Class II-IV); AND Patient must be 18 years; AND Left ventricular ejectin fractin 40% Clinical Criteria fr Frte (teriparatide): Treatment f steprsis in pstmenpausal wmen wh are at high risk fr fracture; OR Increase f bne mass in men with primary r hypgnadal steprsis wh are at high risk fr fractures; OR Treatment f men and wmen with steprsis assciated with sustained systemic gluccrticid therapy at high risk fr fracture; OR Bne mineral density f -3 r wrse; OR Pstmenpausal wmen with histry f nn-traumatic fracture(s); OR Pstmenpausal wmen with tw r mre f the fllwing clinical risk factrs: Family histry f nn-traumatic fracture(s); OR Patient histry f nntraumatic fracture(s); OR DXA BMD T-scre -2.5 at any site; OR 1 year Patient is respnding t treatment Patient is respnding t treatment Quantity limit: 2 tablets per day Patient is respnding t treatment (mre than 2 years is nt recmmended Patient is respnding t treatment

34 Gluccrticid use* ( 6 mnths f use at 7.5 dse f prednislne equivalent); OR Rheumatid Arthritis; OR Pstmenpausal wmen with BMD T-scre -2.5 at any site with any f the fllwing clinical risk factrs: Mre than 2 units f alchl per day; OR Current smker; OR Men w/primary r hypgnadal steprsis; OR Osteprsis assciated w/sustained systemic gluccrticid therapy. * Maximum duratin f therapy is 24 mnths during a patient s lifetime fr Frte GI Antibitics : Alinia Dificid Clinical criteria fr Alinia tablets: Fr treatment f f diarrhea caused by Cryptspridium parvum r Giardia lamblia and if the patient has had a trial n metrnidazle r ral vancmycin r a clinical reasn why it cannt be tried. Clinical criteria fr Alinia Suspensin: In patients 12: Fr treatment f diarrhea caused by Cryptspridium parvum r Giardia lamblia and if the patient has had a trial n metrnidazle r ral vancmycin r a clinical reasn why it cannt be tried. In patients < 12: Fr treatment f diarrhea caused by Cryptspridium parvum r Giardia lamblia n trial n metrnidazle r ral vancmycin required. Alinia: Apprval duratin: 1 time (date f service) Tablets: Quantity limit = 6 tabs per rlling 30 days Suspensin: 3 day supply Dificid: Apprval duratin: 1 time (date f service); 30 days supply

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